UNITED STATES AIR FORCE RESEARCH LABORATORY TESTING AND EVALUATION OF THE INTERNATIONAL BIOMEDICAL, INC., MODEL 20M, NEONATAL TRANSPORT SYSTEM - PDF

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AFRL-HE-BR-TR UNITED STATES AIR FORCE RESEARCH LABORATORY TESTING AND EVALUATION OF THE INTERNATIONAL BIOMEDICAL, INC., MODEL 20M, NEONATAL TRANSPORT SYSTEM MSgt Butch O. Blake AIR FORCE RESEARCH
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AFRL-HE-BR-TR UNITED STATES AIR FORCE RESEARCH LABORATORY TESTING AND EVALUATION OF THE INTERNATIONAL BIOMEDICAL, INC., MODEL 20M, NEONATAL TRANSPORT SYSTEM MSgt Butch O. Blake AIR FORCE RESEARCH LABORATORY HUMAN EFFECTIVENESS DIRECTORATE BIODYNAMICS & PROTECTION DIVISION SYSTEMS RESEARCH BRANCH 2504 Gillingham Dr., STE 25 Brooks AFB, Texas February 2000 Approved for public release; distribution unlimited. mc^^mm8pectb D NOTICES This final technical report was submitted by personnel of the Protection Systems Branch, Biodynamics and Protection Division, Human Effectiveness Directorate, Air Force Research Laboratory, AFMC, Brooks Air Force Base, Texas, under job order This report was prepared as an account of work sponsored by an agency of the United States Government. Neither the United States Government nor any agency thereof, nor any of their employees, nor any of their contractors, subcontractors, or their employees, makes any warranty, expressed or implied, or assumes any legal liability or responsibility for the accuracy, completeness, or usefulness of any information, apparatus, product, or process disclosed, or represents that its use would not infringe privately owned rights. Reference herein to any specific commercial product, process, or service by trade name, trademark, manufacturer, or otherwise, does not necessarily constitute or imply its endorsement, recommendation, or favoring by the United States Government or any agency, contractor, or subcontractor thereof. The views and opinions of the authors expressed herein do not necessarily state or reflect those of the United States Government or any agency, contractor, or subcontractor thereof. When Government drawings, specifications, or other data are used for any purpose other than in connection with a definitely Government-related procurement, the United States Government incurs no responsibility or any obligation whatsoever. The fact that the Government may have formulated or in any way supplied the said drawings, specifications, or other data, is not to be regarded by implication, or otherwise in any manner construed, as licensing the holder or any other person or corporation; or as conveying any rights or permission to manufacture, use or sell any patented invention that may in any way be related thereto. The Office of Public Affairs has reviewed this report, and it is releasable to the National Technical Information Service, where it will be available to the general public, including foreign nationals. This report has been reviewed and is approved for publication. Government agencies and their contractors registered with Defense Technical Information Center (DTIC) should direct requests for copies to: Defense Technical Information Center, 8725 John J. Kingman Rd., STE 0944, Ft. Belvoir, VA Non-Government agencies may purchase copies of this report from, National Technical Information Services (NTIS), 5285 Port Royal Road, Springfield, VA, BLAKE, BUTCH O., MSgt, USAF NCIOC, Air Force Medical Equipment Development Laboratory JAMES C. SYLVESTER, Major, USAF, NC Chief, Air Force Medical Equipment Development Laboratory ROGER L. STORK, Colonel, USAF, BSC Chief, Biodynamics Protection Division REPORT DOCUMENTATION PAGE Form Approved OMB No Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Washington Headquarters Services, Directorate for information Operations and Reports Jefferson Davis Highway. Suite Arlington, VA , and to the Office of Management and Budget Paperwork Reduction Pro ect ( ). Washington, PC 20503, 1. AGENCY USE ONLY (Leave blank) 2. REPORT DATE February REPORT TYPE AND DATES COVERED Final, October TITLE AND SUBTITLE Testing and Evaluation of the International Biomedical, Inc., Model 20M, Neonatal Transport System. 6. AUTHOR(S) 5.FUNDING NUMBERS PE: 62202F PR: 7184 TA: 56 WU:01 Butch O. Blake, MSgt 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Air Force Research Laboratory Human Effectiveness Directorate Biodynamics Protection Division 2504 Gillingham Dr. STE 25 Brooks AFB TX SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) 8. PERFORMING ORGANIZATION REPORT NUMBER AFRL-HE-BR-TR SPONSORING/MONITORING AGENCY REPORT NUMBER 11. SUPPLEMENTARY NOTES 12a. DISTRIBUTION/AVAILABILITY STATEMENT 12b. DISTRIBUTION CODE Approved for public release; distribution unlimited. 13. ABSTRACT (Maximum 200 words) The International Biomedical, Inc., Model 20M, Neonatal Transport System is an infant transport incubator. It provides an environment to support an infant's requirements while being transported. The Neonatal Transport System has a standard infant chamber that circulates warmed air and comes equipped with one main door, one head door, and two hand ports. The Neonatal Transport Systems main door allows access for infant placement inside the infant chamber as well as further access for medical care. To prevent excessive heat loss, the main door has hand ports to allow infant care without opening the main door. The Neonatal Transport System has an accessory module containing a Protocol vital signs monitor, a International Bio-Med MVP-10 ventilator, a Mine Safety Appliance oxygen analyzer, a Impact continuous/intermittent suction device, and intravenous infusions using up to four Baxter syringe pumps. The Neonatal Transport System provides medical grade oxygen and air using internal Q size tanks and/or external gas sources. The unit operates off of 115 VAC/60 and 400 Hz and internal rechargeable battery. The unit weighs approximately lbs. Its dimensions are 37.5 in. W. X 43.0 in. H. X in. D. 14. SUBJECT TERMS Neonatal incubator NTS aeromedical Airworthy aircraft infant warmer 15. NUMBER OF PAGES 16. PRICE CODE SECURITY CLASSIFICATION OF REPORT Unclassified 18. SECURITY CLASSIFICATION OF THIS PAGE Unclassified 19. SECURITY CLASSIFICATION OF ABSTRACT Unclassified 20. LIMITATION OF ABSTRACT UL NSN Standard Form 298 (Rev.2-89) Prae/»rihori hv 1MSI SM 7*Q.-IR r TABLE OF CONTENTS BACKGROUND 1 DESCRIPTION 1 PROCEDURES 2 INITIAL INSPECTION AND TEST PREPARATION 3 TEST SETUP 3 PERFORMANCE CHECK 9 VIBRATION 9 ELECTROMAGNETIC COMPATIBILITY 14 THERMAL/HUMIDITY ENVIRONMENTAL CONDITIONS 16 HYPOBARIC CONDITIONS 16 AIRBORNE PERFORMANCE 17 EXPLOSIVE ATMOSPHERE 17 EVALUATION RESULTS 17 INITIAL INSPECTION 17 VIBRATION 17 ELECTROMAGNETIC COMPATIBILITY 18 THERMAL/HUMIDITY ENVIRONMENTAL CONDITIONS 18 HYPOBARIC CONDITIONS 18 AIRBORNE PERFORMANCE 19 EXPLOSIVE ATMOSPHERE 19 SUMMARY 19 REFERENCES 23 APPENDIX 24 LIST OF FIGURES Figure 1. International Biomedical, Inc., Model 20M Neonatal Transport System 2 Figure 2. Test Setup.8 Figure 3. Vibration Table Mounting 9 Figure 4. Sine-On-Random Z-Axis based on MiI-Std-810E, 10 Figure 5. Sine-On-Random X-Axis based on Mil-Std-810E, 11 Figure 6. Sine-On-Random Y-Axis based on Mil-Std-810E, 12 Figure 7. C-130 Turbo-prop based on Mil-Std-810E, 13 Figure 8. USAF Jet based on Mil-Std-810E, 14 iii ACKNOWLEDGMENTS The author would like to thank those who helped and provided advice during the evaluation of International Biomedical, Inc., Model 20M Neonatal Transport System. The author would especially like to thank the following people: Maj or James Sylvester Program Manager 2Lt Jonathan Raker Biomedical Engineer MSgt Pamela Forest Medical Service Journeyman MSgt Allen Jones Aeromedical Research Technician Mr. Edward Hade Electronics Engineer Mr. Victor Elizondo Electronics Technician IV TESTING AND EVALUATION OF THE INTERNATIONAL BIOMEDICAL, INC., MODEL 20M, NEONATAL TRANSPORT SYSTEM BACKGROUND Air Mobility Command requested the Air Force Medical Equipment Development Laboratory (AFMEDL) participation in evaluating and approving International Biomedical, Inc., Model 20M Neonatal Transport System for use on board USAF aeromedical evacuation aircraft. Specific components of the International Biomedical, Inc., Model 20M Neonatal Transport System that underwent evaluation included: the International Biomedical, Inc., Model 20M basic unit: (S/N: 889); the Baxter, Inc., Syringe Pump Model AS50 (S/N's: AB, AB, AB, AB); the Mine Safety Appliance, Inc., Oxygen Analyzer Model Miniox 3000 (S/N: B765J98, P/N: ); the Impact, Inc., Continuous/Intermittent suction pump, Model 326/326M (S/N: ); the Impact, Inc., Continuous/Intermittent suction pump, Model 326/326M power supply (S/N: ); the International Biomedical, Inc., Air and Oxygen Blender (S/N: KKF01321, P/N: 10065); the Timeter Instruments, Corp., Oxygen Flowmeter, Model Classic 0-16; International Bio-Med, Inc., Pediatric Respirator Model MVP- 10 (S/N: ); Protocol Systems, Inc., Propaq, Model 206EL (S/N: EC001317) with power supply (S/N: Not Available); and the International Biomedical, Inc., Retractable Bar Fastner System (P/N: ) for securing the NTS in Air Force ambulances. All components of the model 20M were tested for airworthiness. Throughout this report, the term Equipment Under Test (EUT) refers to the model 20M and all internal and external components. DESCRD7TION The EUT is an infant transport incubator. It provides an environment to support an infant's requirements while being transported. The EUT's standard infant chamber circulates warmed air and comes equipped with one main door, one head door, and two hand ports. The EUT's main door allows access for infant placement inside the infant chamber as well as further access for medical care. To prevent excessive heat loss, the main door has hand ports to allow infant care without opening the main door. The EUT has an accessory module containing a Protocol vital signs monitor, a International Bio-Med MVP-10 ventilator, a Mine Safety Appliance oxygen analyzer, a Impact continuous/intermittent suction device, and intravenous infusions using up to four Baxter syringe pumps. The EUT provides medical grade oxygen and air using internal Q size tanks and/or external gas sources. The unit operates off of 115 VAC/60 and 400 Hz and internal rechargeable battery. The unit weighs approximately lbs. Its dimensions are 37.5 in. W. X 43.0 in. H. X in. D. Figure 1. International Biomedical, Inc., Model 20M Neonatal Transport System PROCEDURES Test methods and performance criteria were derived from nationally recognized performance guidelines (1 & 2), military standards (3-8), and manufacturer's literature (9). The AFMEDL Procedures Guide describes additional safety and human interface issues to be considered during equipment testing (10). A test setup and performance check was developed specific to this EUT to verify its proper functioning under various testing conditions. All tests were conducted by AFMEDL personnel assigned to the Systems Research Branch, Biodynamics and Protection Division, Human Effectiveness Directorate, Air Force Research Laboratory, Brooks AFB, Texas unless otherwise noted. The EUT was subjected to various laboratory and in-flight tests to observe and evaluate its performance under anticipated operational conditions. 1. Initial Inspection 2. Vibration 3. Electromagnetic Interference (EMI) 4. Thermal/ Humidity Environmental Conditions, encompassing: a. Hot Operation b. Cold Operation c. Humidity Operation d. Hot Temperature Storage e. Cold Temperature Storage 5. Hypobaric Conditions a. Cabin Pressure/Altitude b. Rapid Decompression to simulated flight level 6. Airborne Performance INITIAL INSPECTION AND TEST PREPARATION a. The EUT was inspected for quality of workmanship, production techniques and preexisting damage. b. The EUT was checked to ensure it met safety requirements and operating characteristics established in National Fire Protection Agency (NFPA) 99 (1); AFI41-203, Electrical Shock Hazards (3); AFI , Equipment Management in Hospitals (4). Ground resistance and leakage current measurements were made at 115 VAC/60 Hz and 115 VAC/400 Hz. c. The EUT was examined to ensure it met basic requirements for human factor design as outlined in MIL-STD 1472 (5). d. A test setup and performance check was developed to evaluate the EUT's operation in accordance with manufacturer/customer specifications throughout the various testing conditions. TEST SETUP Test Setup: The nine individual devices that make up the NTS were evaluated together as a system. A series of simulated signals was applied to each device with the resulting performance measured while the NTS was exposed to the stresses of flight. Some devices have been recently tested and certified for flight by AFMEDL. In these cases, prior test results were reviewed and accepted as providing satisfactory demonstration of airborne performance. Individual device descriptions and performance checks are outlined below: Infant Incubator Model 20M: The function of the incubator is to provide a warm environment, adequate ventilation for fresh air exchange, and delivery of external supplemental oxygen (flowmeter or ventilator). Test methods used were similar to those used in previous AFMEDL Model 185 and 20H Transport Incubator evaluations (see USAFSAM-TR-90-23). Three temperature probes/sensors measured the incubator's infant chamber temperature characteristics. Performance Check: The incubator was pre-warmed to 37 C using 110 VAC/60 Hz power under standard ambient conditions. The incubator's infant chamber temperature was measured and recorded throughout each test. The NTS Skin Temperature Probe is plugged into a receptacle located on the NTS control panel It is normally attached to the infant's skin. This thermistor displays the infant's skin temperature by depressing the Skin Temp button on the NTS control panel. A commercial heating pad was used to substitute as a heat source during testing. Performance Check: The following Performance Check was used to validate the function of the NTS Skin Temperature Probe during vibration and environmental testing. Measurements taken during initial operation at standard ambient conditions served as a baseline for later comparison. The performance check for the NTS Skin Temperature Probe is defined below. Procedure: 1. Plug temperature probe into Skin Temp receptacle on NTS control panel. 2. Attach skin probe and second source thermistor to commercial heating pad. 3. Plug NTS and commercial heating pad into 115 VAC/60 Hz power. 4 Turn on NTS, second source thermistor, and commercial heating pad. 5! Place commercial heating pad into infant chamber on NTS and allow NTS temperature to stabilize. 6. Adjust commercial heating pad to low setting and allow temperature to stabilize. 7. Record temperature data from skin probe and second source thermistor. Bio-Med, Model MVP-10 Pediatric Respirator: This device has been previously evaluated by AFMEDL. The device was tested and approved for aerovac as a stand-alone device (May 87) and as a part of the previously aerovac approved NTS (Dec 90). Preformance measurements were only taken during these current efforts during vibration and environmental operational testing. Performance Check: The following performance check was used to validate the function of the Bio-Med Model MVP-10 Pediatric Respirator in each test condition. Measurements taken during initial operation at standard ambient conditions served as a baseline for later comparison. Procedure: 1. Connect the patient breathing circuit from the respirator to a Michigan Instruments, Ventilator Analyzer infant input port. 2. Insert an RP200 resistor inline with the patient breathing circuit at the mask connection to the analyzer. 3. Ventilate the test lung analyzer at the following settings: -Mode: Cycled -Inspiratory Time: Expiratory Time: Airway Pressure: 28 cmh 2 0 -Flow: 41pm -PEEP/CPAP: Off -Fi0 2 : 30% -Breath Rate: Record data using Pneu View (software supplied with the Michigan Analyzer and installed on a laptop computer). Protocol Propaq, Model 206EL Neonatal Monitor: This device has been previously tested and approved for aerovac (August 97) by AFMEDL. Measurements were only taken during vibration and operational environmental testing. Performance Check: The following performance check was used to validate the function of the Propaq 206EL Physiological Monitor in each of the test conditions. Measurements taken during initial operation at standard ambient conditions served as a baseline for later comparison. Procedure: 1. Plug the 3-lead ECG cable into the ECG port on the 206EL 2. Attach the 3 ECG leads to the corresponding color-coded receptacles on a Bio-Tek Multiparameter Simulator (LionHeart 3C). 3. Secure the non-invasive blood pressure (NIBP) tubing line to the NIBP port on the 206EL and the Pressure Port on a Bio-Tek BP Pump tester. Configure the NIBP tester with the following settings: Mode = Infant Settings, Standard set of pressures #1 Systolic = Diastolic = Mean = TBD Heart Rate = Plug the Sp0 2 cord into its corresponding Sp0 2 port on the 206EL. Attach the Sp0 2 sensor to the finger probe on a Bio-Tek Sp0 2 simulator. Set the simulator to monitor for Nellcor pulse oximeters; 98% and 160 bpm. 5. Plug the C0 2 sensor cord into its corresponding port on the 206EL's C0 2 module. Attach an airway adapter and sensor to the C0 2 line. C0 2 module will be hanging and open to ambient conditions. Display should read Srch and no alarm presents. Configure the Propaq 206EL monitor ECG lead H and display temperature in C. The Propaq 206EL will continuously monitor temperature, PI, Sp0 2, and C0 2. Program NIBP operation for automatic at oneminute intervals. Bird, Model 3 800A Air-Oxygen Blender: This device blends compressed air and medical grade oxygen for delivery to a ventilator at 50 psi (+/-5); at percentages determined by the blender control knob; from 21 to 100%. The Bird, Model 3800A is also equipped with an auxiliary outlet for attaching an oxygen flow meter. This device has been previously tested by AFMEDL. This device was tested as a part of the previous NTS model (published Dec 90) therefore, no measurements were taken during this NTS evaluation. Impact Corp., Model 326M, Suction Unit: This device was tested by itself and approved for aerovac (Jan 97) therefore, measurements were only taken during vibration and environmental testing. Performance Check: The following performance check was used to validate the function of the Impact 326M Suction Unit in each of the test conditions. Measurements taken during initial operation at standard ambient conditions served as a baseline for later comparison. The performance check for the Impact 326M is defined below. Procedure(s): The performance check for the Impact 326M consists of four separate tests. These tests are outlined below (1-4). 1. Time to reach 300 mmhg - Attach collection canister with collection tubing to unit, turn unit on, set vacuum adjust to maximum. Occlude tubing and using a stopwatch measure how long unit takes to reach 300 mmhg. Repeat test 3 times and record results. Next, connect a flowmeter in the vacuum line to measure free airflow. Turn unit on and record results. NOTE: Unit must provide a vacuum level of 300 mmhg in four (4) seconds (or less) at 25 lpm free flow. 2. Maximum Vacuum Level - Attach collection canister with collection tubing to unit, select continuous mode, occlude collection tubing, set vacuum adjust to maximum, turn unit on and record results. 3. Vacuum Gauge Accuracy - Attach collection canister with collection tubing to unit, connect a calibrated vacuum gauge to collection tubing, select continuous mode, turn unit on, assess unit's gauge by setting vacuum adjust on unit to read 100,150, 250, 500 mmhg, and record results. NOTE: This test was performed one time during initial'baseline testing. However, a calibrated Universal Biometer, Model DPM-m
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